Recall Z-2158-2016 ยท HWC Screw, Fixation, Bone
Synthes (USA) Products LLC
3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar fe
| Date | Jul 11, 2016 (initiated Feb 16, 2016) |
| Status | Terminated |
| Reason | Labeling does not match the cleared indications for use in the United States and Canada. |
| Root cause | Labeling False and Misleading |
| Action | DePuy Synthes initiated a Field Safety Notice to remove the affected Technique Guides and marketing literature from the field. Sales Consultants and Synthes Trauma Marketing will receive training on affected technique guides and marketing literature which promoted off label use. All technique guides and literature have been put on hold and removed from DePuy Synthes website. Effectiveness of this field action will be tracked using their training system. They will confirm training when completed as a means to measure effectiveness. |
| Quantity | 19,497,844 units in total |
| Distribution | US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021932 | SYNTHES 6.5 MM CANNULATED SCREW Synthes (Usa), Sep 6, 2002 |